Bristol-Myers Squibb buys festinavir, new NRTI active against MDR HIV

Keith Alcorn

Published: 21 December 2010

Bristol Myers-Squibb will pay up to $286 million for
development rights to festinavir, a new once-daily nucleoside reverse
transcriptase inhibitor that is active against viruses resistant to both
tenofovir and abacavir, the company announced on December 20th.

Festinavir is a derivative of d4T (stavudine), but its
developers say it is far less toxic than that drug.

Phase 1a trial data presented at the Intersciences
Conference on Antimicrobial Agents and Chemotherapy in September 2010 showed
that the drug was well tolerated over 10 days of monotherapy in people with
previously untreated HIV infection, and test tube studies suggest that the drug
is approximately 100-fold less toxic to mitochondrial DNA polymerase gamma than
d4T. Mitochondrial toxicity is the cause of the major side-effects associated
with d4T, such as peripheral neuropathy and lipoatrophy, that have led to that
drug’s declining use.

Festinavir was developed at Yale
University in the United States
and licensed to Oncolys BioPharma, a Japanese company.

The greatest promise of festinavir lies in its potential
activity against HIV with high levels of resistance to current nucleoside
analogues. At present no other nucleoside analogue with activity suitable for
use by highly treatment-experienced patients is in credible development, and
festinavir could be useful for tens of thousands of people with HIV with
resistance to three or more drug classes who received extensive prior treatment
with nucleoside analogues in the 1990s.

However this cohort of patients is unlikely to have been
attractive enough on its own to justify Bristol Myers-Squibb’s investment
decision; any company investing $286 million before phase 2 trials have been
conducted must see festinavir as a potential big earner, suitable for hundreds
of thousands of patients.

Bristol-Myers Squibb will now take forward the development
of the drug, seeking to establish the optimal dose. Phase 1a results indicated
little difference in the degree of virlogical suppression between daily doses
of 300mg or 600mg, and as 3TC (lamivudine) goes off patent, it could be
tempting for Bristol-Myers Squibb to pursue a development path that
co-formulates festinavir with its own generic version of 3TC, in a branded
nucleoside analogue combination that competes with Gilead’s Truvada (tenofovir and FTC) and Glaxo
SmithKline’s Kivexa (abacavair and
3TC).

Co-formulation could also allow the company the company to come up with fixed dose
combinations that match the pair with efavirenz or with atazanavir, ensuring
that Bristol-Myers Squibb remains a central player in the HIV drug market for
years to come.

As patents on some of the major elements of HIV therapy
begin to expire between now and 2018, the search for new agents and new drug
classes will be accompanied by an intensification of approaches to
re-formulating drugs in ways that extend the patent life of big earners while
delivering greater convenience in dosing for patients.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap

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checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member
of your healthcare team for advice tailored to your situation.